FDA advisers support full approval of Pfizer’s COVID treatment

FDA advisers support full approval of Pfizer’s COVID treatment

By Leroy Leo and Khushi Mandowara

March 16 (Reuters) – U.S. Food and Drug Administration (FDA) advisers have overwhelmingly backed full approval of Paxlovid, Pfizer’s oral antiviral treatment for COVID-19, for adults at high risk of progression to severe disease.

The FDA’s external expert panel voted 16 to 1 that the drug’s benefits outweigh its risk for some adults with mild to moderate COVID-19.

The agency is expected to issue a formal approval decision before May. She normally follows the advice of her expert advisors, but is not required to do so.

Full approval will allow Pfizer to sell Paxlovid – which consists of two drugs in pill form – at market prices in the private market in the United States, rather than through government contracts as before.

Full approval would also give doctors more flexibility in prescribing the drug and allow the company to expand its advertising campaign.

Thursday’s yes vote came after the FDA and Pfizer provided data that eased concerns that COVID symptoms would return after five days of treatment.

Numerous anecdotal reports of symptoms returning after Paxlovid treatment, including in patients like President Joe Biden and Dr. Anthony Fauci, had raised concerns.

Several panel members said they were reassured by the data presented on the issue of Paxlovid’s rebound.

(Reporting by Leroy Leo and Khushi Mandowara in Bengaluru, with additional reporting by Michael Erman in New York. Editing in Spanish by Javier Leira)

Melissa Galbraith
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